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The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction

Primary Purpose

Meibomian Gland Dysfunction

Status
Active
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Topical Vitamin D eye drop
Topical placebo eye drop
Sponsored by
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction.

Exclusion Criteria:

  • Patients with Vitamin D deficiency
  • Patients taking Vitamin D systemic Supplementation
  • Patient with prior ocular surgeries within previous 6 months.
  • Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease

Sites / Locations

  • Ophthalmic Research center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Prescribe topical placebo eye drop

Prescribe topical Vitamin D eye drop

Arm Description

Outcomes

Primary Outcome Measures

Ocular Surface Disease Index score
The standard questionnaires.

Secondary Outcome Measures

Tear breakup time (TBUT)
time between fluorescein staining of the cul de sac and appearing dry island on the cornea
schirmer1
Millimeter of the standard strip wetting by tear of the patient
Fluorescein staining test
The number of fluorescein stained points on the cornea & conjunctiva based on Oxford classification score

Full Information

First Posted
July 24, 2022
Last Updated
August 8, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05495958
Brief Title
The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Official Title
The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 25, 2022 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In this randomized clinical trial, patients with Meibomian gland dysfunction aged 50 year and more will be enrolled. The Meibomian gland dysfunction diagnosis will confirmed by a cornea specialist. The enrolled patients will be randomly allocated to the treatment and placebo group. The patients in treatment group will receive topical vitamin D every 6 hours daily (25 Microgram/cc or 1000 IU). The control group will receive the same-shape packed drop without vitamin D. The patients in both group will receive the conventional treatment including hot compress and shampoo scrub. The primary outcome is the change in Ocular surface disease index and 5-Item Dry Eye Questionnaire score assessed before the topical treatment and every one-months until 3 months. The secondary outcome measures are Tear breakup time, Schirmer test, Corneal fluorescein staining, Meibomian gland expressibility. The grader and the patients will blind to the study group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prescribe topical placebo eye drop
Arm Type
Placebo Comparator
Arm Title
Prescribe topical Vitamin D eye drop
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Topical Vitamin D eye drop
Intervention Description
25 Microgram/cc or 1000 IU
Intervention Type
Drug
Intervention Name(s)
Topical placebo eye drop
Intervention Description
The same-shape packed drop without vitamin D
Primary Outcome Measure Information:
Title
Ocular Surface Disease Index score
Description
The standard questionnaires.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Tear breakup time (TBUT)
Description
time between fluorescein staining of the cul de sac and appearing dry island on the cornea
Time Frame
3 months
Title
schirmer1
Description
Millimeter of the standard strip wetting by tear of the patient
Time Frame
3 months
Title
Fluorescein staining test
Description
The number of fluorescein stained points on the cornea & conjunctiva based on Oxford classification score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients aged more than 50 years old and suffering from dry eye caused by meibomian gland dysfunction. Exclusion Criteria: Patients with Vitamin D deficiency Patients taking Vitamin D systemic Supplementation Patient with prior ocular surgeries within previous 6 months. Patient with other causes of dry eye, such as aqueous tear deficiency or ocular surface disease
Facility Information:
Facility Name
Ophthalmic Research center
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

The Efficacy and Safety of Topical Vitamin D Drop on Meibomian Gland Function in Patients With Meibomian Gland Dysfunction

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